(59 days)
The VoxelPlus™ is a software application for the for the display and 3D visualization of medical image data derived from various sources (i.e. CT scanners, MRI scanners). Images and data can be acquired, stored, communicated, processed, printed, rendered, and displayed within the system and or across computer networks at distributed locations.
Typical users of this system are trained professionals, including physicians, nurses, and technicians.
Mevisys VoxelPlus™ is a PC-based software application that imports medical images (i.e. CT, MRI modalities) in a DICOM format and provides various functions for rapid and easy review. It includes 3D volume rendering, various MPR, and many 2D analysis tools. The tools manage images, requests, patients, examination etc. over a high-speed network to allow information and images flow throughout a user facility.
The provided text does not contain information about acceptance criteria or specific studies proving the device meets acceptance criteria. The document is a 510(k) summary for the "VoxelPlus™" Picture Archiving Communications System, which primarily focuses on establishing substantial equivalence to a predicate device.
Therefore, I cannot provide the requested information, including the table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth types, or training set information.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).